Salvia BioElectronics Secures $60 Million in Series B Funding to Advance MySalvia Therapy for Migraine Treatment

Have you ever experienced excruciating pain that feels like a heavy hammer striking your head, or as if thousands of steel needles are piercing it simultaneously? For migraine sufferers, this is a nightmare that can strike at any moment. “The pain is indescribable; it feels as though the entire world is spinning. Any sound or faint light feels like sharp needles stabbing directly into my head,” recalled a patient who has suffered from migraines for many years. “During an attack, I can only curl up in a dark room, clutching my head, afraid to breathe too heavily, just hoping the agony will pass quickly.”

Migraine, a common yet highly debilitating neurological disorder, is subtly affecting the lives of hundreds of millions of people worldwide. Statistics indicate that approximately 10%–15% of the global population suffers from migraines, with a similarly substantial number affected in China. Migraine attacks are characterized not only by excruciating headache but also by frequent accompanying symptoms such as nausea, vomiting, photophobia, and phonophobia, causing significant distress to patients. As a result, many patients are unable to work or study normally, struggle to maintain even basic daily activities, and find social participation largely unattainable.

So, are migraine sufferers destined to struggle in endless pain with no hope of relief? Just as everyone eagerly awaits new treatment options, Salvia BioElectronics has brought a ray of hope with its MySalvia therapy, offering new prospects for recovery to migraine patients.

MySalvia therapy, developed by Salvia BioElectronics, centers on its innovative ultra-thin implant. This implant serves as a “secret weapon” tailored specifically for migraine patients, measuring only a few millimeters in thickness yet delivering substantial therapeutic power. Leveraging advanced bioelectronic foil technology, it conforms seamlessly to the cranial anatomy, offering natural comfort akin to a second skin. Compared with conventional treatments, the advantages of this technology are evident. Historically, migraine sufferers have relied heavily on pharmacological interventions; however, many have endured significant distress due to medication side effects and limited efficacy. Meanwhile, more invasive treatment options entail high surgical risks and prolonged postoperative recovery periods, causing considerable disruption to patients’ daily lives and work.

The ultra-thin implant of the MySalvia therapy cleverly avoids these issues. It is implanted directly under the skin of the forehead and back of the head through minimally invasive surgery, making the procedure relatively simple and significantly reducing surgical complexity and risk. Patients recover quickly after the operation and can return to normal life sooner. Moreover, due to its ultra-thin design, the implant is nearly invisible when worn, having no impact on the patient’s appearance or daily activities, thus providing great convenience for patients.

What’s even more remarkable is that MySalvia therapy also comes with a wearable external device interfacing with the implant. Patients can simply press a button to activate neuromodulation therapy according to their individual needs, receiving precise treatment anytime and anywhere. This personalized approach functions like having a dedicated "health steward" for each patient, providing the most suitable treatment plan based on their specific condition, thereby achieving true "personalized customization."

Salvia BioElectronics Successfully Completes $60 Million Series B Financing Round, Led by Innovation Industries with Active Participation from Invest-NL and EIC Fund

As the lead investor, Innovation Industries brings exceptional investment acumen and extensive resources to the medical technology sector. Its confidence in Salvia BioElectronics not only provides substantial financial support but also leverages its broad industry network to accelerate the market entry of the MySalvia therapy, thereby benefiting more patients. The participation of Invest-NL and the EIC Fund further strengthens this financing round. Invest-NL’s commitment to fostering innovation among Dutch enterprises underscores its strong endorsement of Salvia BioElectronics’ innovative achievements in migraine treatment. Meanwhile, as a fund dedicated to supporting innovative European companies, the EIC Fund’s injection of capital and resources will provide robust support for Salvia BioElectronics’ expansion into European and global markets.

This $60 million financing round will provide ample funding for the clinical development of the MySalvia therapy, accelerating the progress of clinical trials to enable this innovative treatment to undergo rigorous medical validation and reach the market more quickly. Meanwhile, the funds will also help the company make comprehensive preparations for the commercial launch of its product, with strong support allocated to every stage—from upgrading production equipment and building a marketing team to expanding sales channels.

With the support of this financing, Salvia BioElectronics will be able to increase its investment in research and development, continuously optimize the MySalvia therapy, and enhance the product’s performance and efficacy. The company can also actively pursue collaborations with medical institutions and academic research organizations to jointly advance research and development in the field of migraine treatment, providing patients with higher-quality and more effective therapeutic options.

(I) Principles of Neuromodulation Technology

The core secret of the MySalvia therapy lies in its sophisticated neuromodulation technology. This technology acts as a highly skilled “neural conductor,” precisely targeting key nerves closely associated with migraines, such as the trigeminal nerve, via ultra-thin implants. During a migraine attack, signal transmission in these nerves becomes abnormal, akin to a chaotic symphony where the sounds of various instruments lose their harmony. The implant used in the MySalvia therapy functions as an intelligent “signal modulator,” delivering mild electrical signals to subtly regulate neural activity, restoring it to normal function and bringing the disordered “symphony” back into harmony.

At the microscopic level, when electrical signals released by the implant act on nerve cells, they affect ion channels on the nerve cell membrane, altering ion influx and efflux, thereby modulating neuronal excitability. In this way, MySalvia therapy effectively blocks signal transmission involved in migraine attacks, alleviates patients' pain symptoms, and brings long-awaited comfort and relief.

(II) Wearable Devices and Applications

In addition to the groundbreaking ultra-thin implant, the MySalvia therapy is equipped with powerful wearable external devices and a smart application that work in close synergy with the implant to comprehensively safeguard patient health.

Wearable external devices act as a “health remote control” in the patient’s hand, offering simple and convenient operation. By simply pressing a button, patients can activate neuromodulation therapy, initiating treatment anytime and anywhere based on their individual needs and sensations. This immediate treatment approach enables patients to take effective measures at the very onset of a migraine attack, significantly enhancing the timeliness and efficacy of therapy. Furthermore, these wearable devices are compact and comfortable to wear, allowing patients to use them effortlessly during work, study, or daily activities without any disruption to their normal lives.

The accompanying application serves as a thoughtful “health consultant,” providing patients with comprehensive health management services. By interacting with data from implants and wearable devices, the application can monitor migraine attacks in real time, capturing key information such as attack frequency, duration, and pain intensity. Leveraging advanced data analytics algorithms and artificial intelligence technologies, the application tailors personalized treatment plans based on this data. It dynamically adjusts treatment parameters in response to changes in the patient’s condition, ensuring precision and efficacy in therapy.

The application also features health reminders to prompt patients to adhere to their treatment schedules, thereby preventing compromised therapeutic outcomes due to oversight. Patients can further log lifestyle habits, dietary intake, and emotional fluctuations within the app; these data provide comprehensive references for physicians and the care team, facilitating a deeper understanding of the patient’s condition and the formulation of more evidence-based treatment plans. Additionally, the application offers an interactive platform where patients can share treatment experiences and insights, offering mutual encouragement to collectively combat disease.

In the RECLAIM study, researchers will recruit a cohort of migraine patients for long-term follow-up. Patients will receive MySalvia therapy, and researchers will meticulously document data on migraine attack frequency, pain intensity, and associated symptoms. Advanced medical diagnostic techniques will be employed to monitor changes in patients’ physiological parameters. Through in-depth analysis of these data, researchers will comprehensively evaluate the therapeutic efficacy of MySalvia therapy, including its ability to effectively reduce the frequency and severity of migraine attacks, alleviate patient suffering, and improve quality of life.

The RECLAIM study will also focus on the safety of the MySalvia therapy. Researchers will closely monitor patients for any adverse reactions during treatment, including the type, severity, and frequency of these reactions. By analyzing safety data, researchers will assess the risk-benefit ratio of the MySalvia therapy, providing a solid safety foundation for its clinical application.

In addition to actively advancing the RECLAIM study, Salvia BioElectronics has established a clear regulatory submission plan, committed to making the MySalvia therapy available to patients worldwide as soon as possible.

In the United States, the company will make every effort to secure authorization from the U.S. Food and Drug Administration (FDA). As one of the most authoritative regulatory agencies for pharmaceuticals and medical devices worldwide, the FDA maintains a rigorous and stringent approval process. Salvia BioElectronics will strictly adhere to FDA requirements by submitting comprehensive and detailed clinical trial data and product documentation, fully demonstrating the safety and efficacy of the MySalvia therapy, with the aim of obtaining FDA approval and paving the way for entry into the U.S. market.

In Europe, the company will actively pursue CE marking. CE marking serves as a passport for products to enter the European market, signifying that they comply with relevant European safety, health, and environmental standards. Salvia BioElectronics will adhere to the requirements of the European Medical Device Regulation (MDR) and complete all necessary certification procedures to ensure the smooth market entry of the MySalvia therapy, thereby bringing significant benefits to migraine patients in Europe.

The company also plans to obtain regulatory approval in regions such as Australia. With its well-established medical regulatory framework, securing approval in Australia will help enhance the international recognition and influence of the MySalvia therapy. By actively pursuing regulatory approvals in multiple regions, Salvia BioElectronics will gradually expand the global market for the MySalvia therapy, enabling more migraine patients to benefit from this innovative treatment.

In addition to demonstrating significant potential in the treatment of migraine, MySalvia therapy has also shown promising possibilities for the management of cluster headache. Cluster headache, another exquisitely painful neurological disorder, has a relatively lower incidence than migraine; however, the severity of pain during attacks is often so excruciating that patients experience unbearable suffering.

“The pain felt like a red-hot iron being pressed directly against my temple; every second was pure agony.” Recalling an attack, a patient with cluster headache still shuddered at the memory. “During each episode, I felt as if my head were about to explode—life became worse than death.” The attack pattern of cluster headache differs from that of migraine. It typically presents as severe unilateral pain around the orbit or in the forehead. Although the attacks are relatively short in duration, the pain intensity is extremely severe and is often accompanied by symptoms such as conjunctival injection, lacrimation, and nasal congestion, causing significant physical and psychological distress to patients.

The research team at Salvia BioElectronics believes that the neuromodulation technology of the MySalvia therapy could bring significant benefits to patients with cluster headaches. Theoretically, the pathogenesis of cluster headaches is closely related to abnormal activity in the nervous system. By precisely targeting key nerves and modulating neural activity, the MySalvia therapy has the potential to effectively alleviate the symptoms of cluster headaches.

Many experts have also expressed optimism about the application of this therapy in the treatment of cluster headaches. A neurology expert pointed out, “The innovation of the MySalvia therapy lies in its ability to directly act on nerves, modulating neural function at its source. This precise neuromodulation approach provides new insights and methods for treating cluster headaches. If clinical trials can confirm its efficacy, it will bring new hope to patients with cluster headaches.” Currently, although relevant clinical trials are still ongoing, preliminary research results have already shown positive signals. It is believed that in the near future, the MySalvia therapy is expected to become a lifeline for patients with cluster headaches, helping them break free from the torment of pain and regain freedom and joy in their lives.

Salvia BioElectronics’ explorations and breakthroughs in the field of migraine treatment have undoubtedly brought new hope to migraine patients worldwide. From initial technology development to the successful completion of a $60 million Series B financing round, and further to the active advancement of clinical trials and regulatory submissions, each step reflects the wisdom and dedication of the company’s team, underscoring their firm commitment to alleviating patient suffering.

Currently, the MySalvia therapy has demonstrated promising preliminary results in the RECLAIM study. As research deepens and clinical trials advance, it is anticipated that MySalvia therapy will successfully secure regulatory approval and launch on the market in the near future, providing substantial relief to migraine patients. At that time, countless individuals suffering from migraines will have the opportunity to break free from the constraints of their condition, embrace a better quality of life, engage freely in social activities, pursue their careers without concern, and fully enjoy the pleasures of life.

The potential of MySalvia therapy in the treatment of cluster headaches has also ushered in a new dawn for this field. If successfully applied to the treatment of cluster headaches in the future, it will bring great benefit to patients and open a new chapter in their lives.

Let us look forward to Salvia BioElectronics achieving even greater breakthroughs in the treatment of migraine and cluster headaches, enabling more patients to benefit from this innovative therapy and regain their health and freedom. We also encourage everyone to continue following developments in this field, supporting the advancement of medical technology, and witnessing the emergence of medical miracles together.

This Issue's FeatureShen Li

Responsible Editor: Chen Baolin

Author of this article: Yunyexuan

Post-Production: Zhang Lirong